Rienso (ferumoxytol)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- ferumoxytol
- Company
- Takeda Pharma A/S
- Status
- Withdrawn
- Therapeutic area
- Anemia; Kidney Failure, Chronic
- EU approval
- Fri 15 Jun 2012
- Designations
- Additional monitoring
- Application
- EMEA/H/C/002215
- ATC
- B03
- Official record
- www.ema.europa.eu
Indication
Rienso is indicated for the intravenous treatment of iron-deficiency anaemia in adult patients with chronic kidney disease (CKD). The diagnosis of iron deficiency must be based on appropriate laboratory tests (see section 4.2).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇺🇸 Ferabright Approved · Azurity
- 🇪🇺 Feraheme Application withdrawn · Covis Pharma Europe B.V.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.